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Listening to Mom in the NICU: Neural, Clinical and Language Outcomes

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Language Treatment
Control Treatment
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring Premature Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications

Eligibility Criteria

24 Weeks - 31 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants born preterm at Stanford Children's Hospital between 27 0/7 - 31 6/7 weeks gestational age

Exclusion Criteria:

  • Congenital anomalies
  • Recognizable malformation syndromes
  • Active seizure disorders
  • History of Central Nervous System infections
  • Hydrocephalus
  • Major sensori-neural hearing loss
  • Likelihood to be transferred from NICU to alternate care facility or home environment prior to 36 weeks PMA
  • Intraventricular Hemorrhage Grades III-IV
  • Cystic periventricular leukomalacia (PVL)
  • Surgical treatment for necrotizing enterocolitis
  • Small for gestational age (SGA) <3 percentile and/or Intra-uterine growth restriction (IUGR) no head sparing
  • Twin-to-twin transfusions

Sites / Locations

  • Stanford University - Lucile Packard Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Language Treatment Arm

Control Treatment Arm

Arm Description

An infant participant randomized to the language treatment arm will be played recordings of his/her mother's voice 2-3 hours daily in the intermediate care nursery until discharge.

An infant participant randomized to the control treatment arm will receive standard of care. Standard of care does not include being played recordings of his/her mother's voice while admitted to the intermediate care nursery. However, an infant randomized to the control treatment will have the same auditory equipment placed in his/her isolette or crib as an infant randomized to the Language Treatment Arm.

Outcomes

Primary Outcome Measures

White matter mean diffusivity
Mean diffusivity measures the average rate of water diffusion within a given MRI voxel.

Secondary Outcome Measures

Length of hospital stay
Days in hospital since birth and until discharge
Average daily weight gain
Time (days) to full oral feed
days until 100 % of nutrition administered orally
Number of significant apnea and bradycardia events requiring stimulation

Full Information

First Posted
July 21, 2016
Last Updated
October 27, 2021
Sponsor
Stanford University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02847689
Brief Title
Listening to Mom in the NICU: Neural, Clinical and Language Outcomes
Official Title
Listening to Mom in the Neonatal Intensive Care Unit (NICU): Neural, Clinical and Language Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 12, 2019 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.
Detailed Description
Children born preterm are at-risk for developmental language delays. Language problems in preterm children are thought to be related to neurobiological factors, including injuries to white matter structures of the brain and environmental factors, including decreased exposure to maternal speech in the hospital nursery. There is evidence to suggest that maternal speech input may be important for promoting healthy brain and language development. Participants will be randomly assigned to one of two study groups. Each infant has a 50% chance of being assigned to the group that will listen to a recording of his/her mother's voice and a 50% chance of being assigned to the group that will not be played a voice recording. Mother's of participating infants will have her voice recorded as she reads a common children's storybook. Recordings will be played to infants each day until s/he is discharged from the hospital. Participation in this study requires that all infants receive up to an additional 10 minutes of brain scans as part of his/her routine clinical magnetic resonance imaging (MRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Premature Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Language Treatment Arm
Arm Type
Experimental
Arm Description
An infant participant randomized to the language treatment arm will be played recordings of his/her mother's voice 2-3 hours daily in the intermediate care nursery until discharge.
Arm Title
Control Treatment Arm
Arm Type
Sham Comparator
Arm Description
An infant participant randomized to the control treatment arm will receive standard of care. Standard of care does not include being played recordings of his/her mother's voice while admitted to the intermediate care nursery. However, an infant randomized to the control treatment will have the same auditory equipment placed in his/her isolette or crib as an infant randomized to the Language Treatment Arm.
Intervention Type
Behavioral
Intervention Name(s)
Language Treatment
Intervention Description
Recording of a mother's voice reading a children's storybook.
Intervention Type
Behavioral
Intervention Name(s)
Control Treatment
Other Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
White matter mean diffusivity
Description
Mean diffusivity measures the average rate of water diffusion within a given MRI voxel.
Time Frame
36-37 weeks post-menstrual age or at time of hospital discharge, whichever comes first
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Days in hospital since birth and until discharge
Time Frame
Days in hospital since birth and until discharge, average range is 37-40 weeks postmenstrual age (PMA)
Title
Average daily weight gain
Time Frame
measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Title
Time (days) to full oral feed
Description
days until 100 % of nutrition administered orally
Time Frame
measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Title
Number of significant apnea and bradycardia events requiring stimulation
Time Frame
measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
31 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants born preterm at Stanford Children's Hospital between 27 0/7 - 31 6/7 weeks gestational age Exclusion Criteria: Congenital anomalies Recognizable malformation syndromes Active seizure disorders History of Central Nervous System infections Hydrocephalus Major sensori-neural hearing loss Likelihood to be transferred from NICU to alternate care facility or home environment prior to 36 weeks PMA Intraventricular Hemorrhage Grades III-IV Cystic periventricular leukomalacia (PVL) Surgical treatment for necrotizing enterocolitis Small for gestational age (SGA) <3 percentile and/or Intra-uterine growth restriction (IUGR) no head sparing Twin-to-twin transfusions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine E Travis, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University - Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Listening to Mom in the NICU: Neural, Clinical and Language Outcomes

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